Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
This transcript has been edited for clarity.
Hello. I’m Dr Maurie Markman, from City of Hope. I want to briefly present the final analysis of overall survival for the LACC trial. This particular trial, which had been reported in the past, looked at the laparoscopic approach to cervical cancer. That’s what LACC stands for.
This was a randomized phase 3 trial. It was a noninferiority trial that was designed to demonstrate the clinical utility of a laparoscopic approach. This particular analysis is “Final Analysis on Overall Survival Comparing Open Versus Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer”, and this included stage IA2 to IB2 cervical cancer.
I think many of you, perhaps most of you, know what the prior results of this study demonstrated, which were focused on progression-free survival, and that is that women who underwent the laparoscopic approach experienced an inferior progression-free survival.
What we are looking at here are their final survival data. At 4.5 years, the women who underwent the laparoscopic approach had a 90.6% chance of survival vs those who underwent the open, standard approach of 96.2%, so somewhere between a 5% and 6% lower survival with the laparoscopic approach.
Again, we already knew the data on progression-free survival. This confirms the inferiority of that approach on overall survival.
I think it’s, again, a sobering lesson and hopefully one that has been learned. When you’re talking about innovative approaches — obviously, throughout oncology, but here we’re talking about innovative surgical approaches — it may sound very exciting. The argument may be that it’s less invasive, easier for patients to recover, and easier for surgeons. There may be even some financial benefits to an institution.
The facts are that we need to do prospective, phase 3 randomized trials to demonstrate — again, in this case — that it was noninferiority. They weren’t saying it was better. They were going to say it wasn’t inferior, but it was inferior.
We need to do these studies to demonstrate the value. Obviously, piloting something makes sense because you need to know that it’s safe and that you know how to do it. Before it gets accepted as the standard of care, just like what we do in the medical oncology sphere, we need to prove surgery’s value in a well-designed, prospective, phase 3 randomized trial.
Thank you for your attention.